BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

    FDA 510(k)
    FDA Class 2 ·Hematology

    PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA·Product code MNI·April 17, 2013

    GOLDLINE REUSABLE PUSH BUTTON ELECTROSURGICAL PENCIL

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code GEI·April 29, 2013

    PROPEX

    FDA Adverse Event
    Malfunction ·DENTSPLY MAILLEFER·Product code LQY·April 13, 2011

    CE INFUSOR LV 2, 12 PACK

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code MEB·July 28, 2008

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018